Exenatide and Metformin Therapy in Overweight Women With PCOS

NCT00344851 | Completed Phase 2

• 1 other identifier: RP06-010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Current research has shown that the use of diabetes management practices aimed at reducing insulin resistance and hyperinsulinemia (such as weight reduction and the administration of oral antidiabetic drugs) in women with PCOS can not only improve glucose and lipid metabolism but can also reverse testosterone abnormalities and restore menstrual cycles. A new medicine called exenatide (Byetta) has been found to reduce body weight, as well as, improve abnormal glucose metabolism in diabetics. This randomized study will compare Exenatide (Byetta) to extended release metformin (Fortamet) to combination therapy (both Byetta and Fortamet) on menstrual cyclicity, hormone profiles and metabolic profiles over a 24-week period in women with PCOS.

Conditions

Polycystic Ovary Syndrome

Keywords

menstrual cyclicity; insulin resistance; body fat distribution; pancreatic ß-cell function; inflammatory markers; liver function tests

Outcome Measures

Primary Outcomes (1)

• - Menstrual Cyclicity ( # menses/ 24 weeks)

  every 4 weeks

Secondary Outcomes (4)

• BMI, WHR, FAI (T/SHBG), DHEAS, lipids,abdominal girth,

  BMI,WHR,abdominal girth at start,12 weeks and 24 weeks, FAI, DHEAS, lipids at start and at 24 weeks

• insulin resistance-(HOMA and composite insulin sensitivity index [ SIOGTT),

  at start and at 24 weeks

• and pancreatic ß-cell function (corrected insulin response [CIRgp] and

  at start and at 24 weeks

• insulinogenic index [IGI] ).

  at start and at 24 weeks

Interventions

metformin, exenatide or combined (metformin & exenatide ) DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must have six or fewer menses /year or be amenorrheic
• Have either clinical or laboratory evidence of hyperandrogenism (hirsutism or elevated testosterone (T)) and /or PCOS ovary on ultrasound

You may not qualify if:

• other uncorrected endocrinopathy- hyperprolactinemia, hyper- or hypothyroidism, congenital adrenal hyperplasia or presence of overt diabetes alterations in hepatic or renal function use of hormonal medications, insulin sensitizers or medications that interfere with carbohydrate metabolism for at least 8 weeks Known active substance abuse including tobacco and alcohol. Pregnancy, breastfeeding or desire for pregnancy during study interval (6 months

Sponsors & Collaborators

• Metabolic Center of Louisiana Research Foundation: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (1)

Facility: Metabolic Center of Louisiana Research Foundation

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (1)

• Elkind-Hirsch K, Marrioneaux O, Bhushan M, Vernor D, Bhushan R. Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Jul;93(7):2670-8. doi: 10.1210/jc.2008-0115. Epub 2008 May 6.

  PMID: 18460557 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Interventions

Metformin; Exenatide

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Officials

• Karen E Elkind-Hirsch, Ph.D.

  Woman's Health Research Institute

  PRINCIPAL INVESTIGATOR

• Rajat Bhushan, M.D.

  Metabolic Center of Louisiana Resarch Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 27, 2006
• Study Start: June 1, 2006
• Study Completion: June 1, 2007
• Last Updated: July 11, 2007

Record last verified: 2007-07

Locations

US (1)